Computer System Validation (CSV) Engineer

• Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
• Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
• Create and modify validation documentation including but not limited to:
• User Requirements Specifications (URS)
• Design Reviews (DR)
• Criticality assessments
• CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements
• Reports which summarize the results of the protocol executions
• Exception reports which identify defects or issues during test execution
• Review vendor documentation
• Continuous improvement on validation process and procedure
• Assist or coordinate generation of Standard Operating Procedures (SOPs)
• Follow the proper site safety practices; wearing adequate safety equipment when required

Job Requirements:

• Degree in Engineering or Science discipline. Preferably in Electrical Engineering, Computer Science/Information Technology, or Chemical/Biochemical/Mechanical Engineering.
• Minimum 3 years of experience in Pharmaceutical Industry
• Proven track record in promoting safety practices in related role
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
• Proactive, self-starter and capable of working alone or in a team environment.
• Familiar with Microsoft office suite of applications
• Ability to interpret and operate within defined schedules managing available resources to achieve project milestones
• Previous DCS (DeltaV), WinCC, SIEMENS and Rockwell automation systems testing experience required
• Experienced in developing automation protocols
• Good knowledge of cGMP, GAMP, GDP, 21CFR Part 11 and ICH Q10 guidelines
• Knowledge of ASTM 2500E risk-based approaches
• To be aware and supportive of the project’s requirement for flexibility in working hours/shift patterns through the differing phases of the project’s life cycle
• Experience with Quality Change Control is desirable
  
  EA License No : 19C9587